New metal rod shows promise for healing broken thighs
NCT ID NCT05523635
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at how well the Gamma4 nail system works for fixing thigh bone fractures. 100 adults who needed this surgery were followed for a year to see if their bones healed and to check for any problems. The goal was to see if the nail helps bones heal properly without causing harm.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gamma4 Nailing System (a metal rod inserted into the thigh bone to stabilize fractures)
- What this could lead to
- If successful, this study confirms that the Gamma4 nail system is a safe and effective option for treating thigh bone fractures.
- What could go wrong
- This is a small, completed study with no comparison group, so results may not apply to all patients. Device-related complications like infection or implant failure are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
100 people
The number who actually took part.
- Started
-
Mar 2023
- Finished
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Oct 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Approximately 100 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for treatment of femoral fractures and deformities with a cephalomedullary nail will be evaluated for clinical investigation participation based on the eligibility criteria.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subject is a male or non-pregnant female age 18 years or older at the time of surgery; * Subject is willing and able to give written informed consent and comply with the requirements of this Clinical Investigation Plan; and * Subject has or is intended to be treated with the Gamma 4 System in accordance with its legally approved Indication for Use (IFU). Indication For Use in the United States and Canada: The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone). Exclusion Criteria: * Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device clinical investigation that, in the opinion of the Investigator, may confound results * Subject with exclusion criteria required by local law * Subject who is, or will be, inaccessible for follow-up * Per the Investigator, the subject is in poor general health or undergoing any concurrent disease that would place the subject in excessive risk to surgery (i.e., significant circulatory problems, cardiac disease). * Any active or suspected latent infection or marked local inflammation in or about the affected area * Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site * Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation of the devices * Material sensitivity, documented or suspected * Patients having inadequate tissue coverage over the operative site * Implant utilization that would interfere with anatomical structures or physiological performance * Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care * Other medical or surgical conditions which would preclude the potential benefit of surgery.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Inova Health Care Services
Falls Church, Virginia, 22042, United States
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MetroHealth
Cleveland, Ohio, 44109, United States
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SSM Health - Madison
Madison, Wisconsin, 53715, United States
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UT Health
San Antonio, Texas, 78229, United States
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William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
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